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    K Number
    K122246
    Device Name
    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
    Manufacturer
    CELLERATION, INC.
    Date Cleared
    2012-08-13

    (17 days)

    Product Code
    NRB
    Regulation Number
    878.4410
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called the MIST® 360° Therapy System. This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements. It does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way a clinical study report or a technical summary would.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications from the provided text. This document is a regulatory communication, not a performance study summary.

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